Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer

This study has been terminated.
(Further evaluation of phase I dosing)
Sponsor:
Collaborator:
Progen Pharmaceuticals
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585416
First received: December 21, 2007
Last updated: April 13, 2009
Last verified: April 2009

December 21, 2007
April 13, 2009
June 2006
November 2007   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585416 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: Throughout and for 28 days post drug ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer
A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)

The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: CGC-11047
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
Experimental: 1
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
Intervention: Drug: CGC-11047
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
March 2009
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Metastatic hormone refractory prostate cancer.
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
  • testosterone <50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
  • Progressive disease after androgen deprivation.

Exclusion Criteria:

  • Patients whose clinical condition would make chemotherapy clearly indicated.
  • Patients who have received systemic chemotherapy for the treatment of metastatic disease.
  • Peripheral neuropathy > Grade 1
  • Prior anti-angiogenic therapy, including thalidomide.
  • Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
  • Patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
  • Patients with known brain metastases or history of brain metastases.
  • History of stroke within 6 months of treatment or other significant neurological limitations.
  • Patients who have received more than 2 prior investigational treatments.
  • Uncontrolled intercurrent illness
  • Patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585416
HSC2006-0099, CO06801, 47-02-001
Yes
George Wilding, PI for this study at University of Wisconsin, University of Wisconsin
University of Wisconsin, Madison
Progen Pharmaceuticals
Not Provided
University of Wisconsin, Madison
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP